BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACU FIX

    MDR report key: 972688 · Received May 7, 2007

    Report

    Report Number
    1649384-2007-00025
    Event Type
    Malfunction
    Date Received
    May 7, 2007
    Date of Event
    April 9, 2007
    Report Date
    May 7, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE EVENT WAS PERFORMED BY REVIEWING THE DEVICE HISTORY RECORDS AND PERFORMING A VISUAL INSPECTION OF THE RETURNED SCREW. THE INVESTIGATION FOUND WEAR OF THE ANODIZATION OF THE BEVEL OF THE SCREW WHICH IS CONSISTENT WITH INSERTION OUTSIDE OF THE RECOMMENDED TRAJECTORY. BASED ON A PREVIOUS INVESTIGATION FOR THIS ISSUE, RCR WAS SUBMITTED IN NOVEMBER 2005 TO MODIFY SURGICAL TECHNIQUE TO UPDATE THE TRAJECTORY OF SCREW PLACEMENT. THIS EVENT OCCURRED AFTER THE RELEASE OF THE UPDATED SURGICAL TECHNIQUE. THE INVESTIGATION CONCLUDED THE EVENT IS A RESULT OF FAILURE TO FOLLOW THE SURGICAL TECHNIQUE. THIS IS THE FIRST EVENT FOR THIS SURGEON THAT HAS BEEN REPORTED. NO FURTHER ACTION IS REQUIRED. MONITORING OF EVENTS OF THIS NATURE INDICATES THE PREVIOUS ACTION HAS BEEN EFFECTIVE. NOTE: A REPORT OR OTHER INFO SUBMITTED BY A REPORTING ENTITY UNDER THIS PART, AND ANY RELASE BY FDA OF THAT REPORT OF INFO, DOES NOT NECESSARILY REFLECT A CONCLUSION BY THE PARTY SUBMITTING THE REPORT TO FDA THAT THE REPORT OF INFO CONSTITUTES AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, OR ITS EMPLOYEES OR AGENTS CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE REPORTING ENTITY NEED NOT ADMIT AND MAY DENY (AND MAY EXPRESSLY RESERVE THE RIGHT TO DENY) THAT THE DEVICE, THE PARTY SUBMITTING THE REPORT OR EMPLOYEES THEREOF CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IN 2007, A PT UNDERWENT REVISION SURGERY OF THE ANTERIOR CERVICAL FUSION DUE TO THE SCREW PULLING THROUGH THE LOCKING RING OF THE PLATE AS IDENTIFIED VIA X-RAY. THE SURGEON REPLACED THE HARDWARE WITH ANOTHER MFR'S INSTRUMENTATION WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACU FIX 14 MM WIDE ROOT SCREWS KWQ ABBOTT SPINE, INC. NA 38WC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 10403-2042, SLIMLINE HYBRID PLATE (ACUFIX)